Investigating T Cells in the Nasal Mucosa of Older Adults
TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals
This study looks at how aging affects certain immune cells in the noses of older adults to see if this might make them more prone to respiratory infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06039527 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how aging affects the mucosal immune system, particularly focusing on T cells in the nasal mucosa of older adults. By utilizing minimally-invasive nasal sampling methods, the study will compare the presence and characteristics of CD4+ and CD8+ T cells in young adults versus healthy and frail elderly individuals. The goal is to understand the mechanisms behind the loss of these immune cells and how this loss may contribute to increased susceptibility to respiratory infections in older adults. Participants will include young adults and older adults categorized by health status and frailty.
Who should consider this trial
Good fit: Ideal candidates for this study include healthy and frail elderly individuals over 65 years old, as well as young adults aged 18-30.
Not a fit: Patients with chronic respiratory conditions such as asthma or COPD, or those currently using inhalation corticosteroids, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential interventions to enhance immune responses in older adults, reducing their risk of respiratory infections.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated that understanding immune responses in older adults is crucial, suggesting potential for success in similar investigations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: •Adults able and willing to provide informed consent. Specific inclusion criteria per group: * Young adults aged 18-30 years old * Healthy elderly aged \>65 years old * Frail elderly \>65 years old * Clinical Frailty score healthy elderly 1-3 * Clinical Frailty score frail elderly \>3 * Self-reported respiratory tract infection in previous year healthy elderly 0-1 * Self-reported respiratory tract infection in previous year frail elderly 0-1 or \>1 Exclusion Criteria: * Incompetence to provide informed consent prior or during study * Current smoker or \>40 pack year history * History of severe nose bleedings * Diagnosed with asthma, COPD or chronic rhinosinusitis * Use of inhalation corticosteroids or antibiotics in the past 6 weeks * Current use of anti-coagulants (to prevent nosebleeds). Platelet inhibitors like acetylsalicylzuur (Ascal) are allowed. * Respiratory tract infection or common cold in the past 2 weeks * Immunocompromised individuals (with primary immune deficiency or secondary immune deficiency) * Life expectancy \<28 days in the opinion of study physician * Vaccination in the 2 months prior to study start. A potential subject that is only excluded from participation based on a recent vaccination will be asked to re-participate 2 months post vaccination.
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Simon P Jochems, PhD — Lumc
- Study coordinator: Simon P Jochems, PhD
- Email: s.p.jochems@lumc.nl
- Phone: +31715261328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.